Efficacy Of Secukinumab Vs Adalimumab in the treatment Of Hidradenitis Suppurativa: A Randomized Controlled Trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical response to treatment by assessing modified sartorius score
研究概览
简要总结
This study is a randomized open labelled parallel group single centre trial to compare the safety and efficacy of secukinumab 300 mg and adalimumab 120 mg every 4 weekly for 6 months in 40 patients of hidradenitis suppurativa not responding to conventional therapies for more than 12 months.The study will be conducted in a tertiary care military hospital .Our primary objective is to compare the efficacy of secukinumab and adalimumab by assessing the clinical response in the form of modified sartorius score at 4 weekly intervals. The secondary objective is to assess the clinical response via patient satisfaction level and hurley staging. All the enrolled patients will be assessed at baseline followed by 4,8,12,16,20 and 24 weeks. Data will be assessed using appropriate statistical test for each of the variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Diagnosed cases Of Hidradenitis Suppurativa with poor response to conventional therapy for more than 12 months.
排除标准
- •Pregnant ladies, autoimmune disorders, immunocompromised patients.
结局指标
主要结局
Clinical response to treatment by assessing modified sartorius score
时间窗: 4 weekly
次要结局
- Clinical response to treatment by assessing hurley staging & patient satisfaction level(4 weekly)
研究者
Debatraya Paul
Military Hospital Jaipur
